FDA Approves Medicines360’s sNDA for LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg to Prevent Pregnancy for up to Five Years

DUBLIN and SAN FRANCISCO, /PRNewswire/ --Allergan,plc (NYSE:AGN), a leading global pharmaceutical company, and Medicines360, a global nonprofit women’s health pharmaceutical company with a mission of expanding access to quality medicines, announced that the U.S. Food and Drug Administration (FDA) approved Medicines360’s Supplemental New Drug Application (sNDA) to extend the duration of use of LILETTA^® (levonorgestrel-releasing intrauterine system) 52 mg for the prevention of pregnancy for up to five years.

“A large and diverse population of women already use LILETTA as a safe, long-acting and reversible contraceptive option. This approval means that LILETTA is now indicated for up to 5 years of use. To date, no hormonal IUD has been studied across more women in a single Phase 3 clinical trial conducted in the U.S.,” said Jessica Grossman, M.D., CEO of Medicines360. “In partnership with Allergan, we remain steadfast in our mission to help women access available birth control methods that are appropriate for them, regardless of their income.”

The FDA approval was based on a review of additional efficacy and safety data from the largest ongoing intrauterine system (IUS), otherwise known as intrauterine device (IUD), Phase 3 clinical trial in the U.S., ACCESS IUS (A Comprehensive Contraceptive Efficacy & Safety Study of an IUS), with 1,751 U.S. women receiving LILETTA. LILETTA proved to be more than 99 percent effective in preventing pregnancy for up to 5 years in a broad range of women. LILETTA is effective regardless of age, race, body mass index (BMI) or parity (whether or not the woman had given birth to at least one child).

“I hear from women every day that they want contraceptive options that are proven and provide them with flexibility in preventing pregnancy. Unfortunately, this isn’t always a reality,” said Thomas Kimble, M.D., associate dean, assistant professor of obstetrics and gynecology, Eastern Virginia Medical School and principal investigator in the pivotal ACCESS IUS study. “I can confidently recommend LILETTA as a rigorously tested choice for patients who want long-term reversible birth control. The fact that it is now indicated for up to five years, instead of four, offers my patients the flexibility of use for either long- or short-term contraception.”

LILETTA is a hormone-releasing system placed in a woman’s uterus to prevent pregnancy for up to five years. The system should be replaced after five years if continued use is desired. Medicines360 received initial approval of LILETTA in February 2015. Since then, Medicines360 and Allergan have continued to invest in the product, which has led to the introduction of the single-handed inserter and, now, the extended duration of use for up to 5 years.

LILETTA is commercially available in the U.S., and through Medicines360’s unique mission-driven model, LILETTA is available at a lower cost to public health clinics enrolled in the 340B Drug Pricing Program.

“In our view, this is a landmark approval because it gives women, regardless of income, insurance status or geography, access to an effective and long-term form of hormonal contraception,” said David Nicholson, Ph.D., Allergan’s chief research and development officer. “We are pleased to strengthen our portfolio of contraceptive options and to continue delivering on our mission of helping women access a method that may be suited for them.”

ABOUT LILETTA®

Indication

LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg is a hormone-releasing system placed in your uterus to prevent pregnancy for as long as you want for up to 5 years.

Important Risk Information About LILETTA

• Do not use LILETTA if you:
  • Are or might be pregnant; LILETTA cannot be used as an emergency contraceptive
  • Have a serious pelvic infection called pelvic inflammatory disease (PID) or endometritis unless you have had a normal pregnancy after the infection went away (PID occurs in less than 1% of users)
  • Have an untreated lower genital infection now
  • Have had an infection from an abortion within the last 3 months
  • Can get infections easily; for example, if you:
    • Have problems with your immune system
    • Have multiple sexual partners or your partner has multiple sexual partners
    • Use or abuse intravenous drugs
  • Have or suspect you might have cancer of the uterus or cervix
  • Have bleeding from the vagina that has not been explained
  • Have short-term (acute) liver disease or liver tumor
  • Have breast cancer or any other cancer that is sensitive to progestin (a female hormone), now or in the past
  • Have an intrauterine system (IUS) in your uterus already
  • Have a condition of the uterus that changes the shape of the uterine cavity, such as large fibroid tumors
  • Are allergic to levonorgestrel, silicone, polyethylene, or barium sulfate
• Call your healthcare provider right away if you think you are pregnant. If you get pregnant while using LILETTA, you may have an ectopic pregnancy, which means the pregnancy is not in the uterus. Unusual vaginal bleeding or abdominal pain especially with missed periods may be a sign of ectopic pregnancy. Ectopic pregnancy can cause internal bleeding. There are also risks if you get pregnant while using LILETTA and the pregnancy is in the uterus. Severe infection and premature labor or delivery can occur with pregnancies that continue with an IUS
• Although uncommon, pregnancy while using LILETTA can be life threatening and may result in loss of pregnancy or fertility
• Bleeding and spotting may increase in the first 3 to 6 months and remain irregular. Periods over time usually become shorter, lighter or may stop
• Life-threatening infection can occur within the first few days after LILETTA is placed. Call your healthcare provider immediately if you develop severe pain or fever shortly after LILETTA is placed
• Some IUS users get a serious pelvic infection called pelvic inflammatory disease (PID) or endometritis. These are usually sexually transmitted. You have a higher chance of getting PID or endometritis if you or your partner has sex with other partners. PID or endometritis can cause serious problems such as infertility, ectopic pregnancy or pelvic pain that does not go away. More serious cases of PID or endometritis may require surgery. Removal of the uterus (hysterectomy) is sometimes needed. In rare cases, infections that start as PID or endometritis can even cause death. Tell your healthcare provider right away if you have any of these signs of PID or endometritis: long-lasting or heavy bleeding, unusual vaginal discharge, low abdominal pain, painful sex, chills, or fever
• LILETTA may become attached to (embedded) or go through the uterus (perforation). If perforation occurs, LILETTA may move outside the uterus and can cause internal scarring, infection, or damage to other organs and you may need surgery to have LILETTA removed. Risk of perforation is increased in breastfeeding women
• LILETTA may come out of your uterus (expulsion). Expulsion occurs in about 4 out of 100 women, most often in the first year of use. You may become pregnant if LILETTA comes out. If you think that LILETTA has come out, use another birth control method like condoms and spermicide or do not have sex (vaginal intercourse) until you are seen by a healthcare provider
• Ovarian cysts may occur but usually disappear

LILETTA does not protect against HIV or STDs.

For full prescribing information, visit www.LILETTA.com.

About Medicines360

Medicines360, located in San Francisco, California, is a nonprofit global women’s health pharmaceutical company with a mission to expand access to quality medicines for all women regardless of their socioeconomic status, insurance coverage or geographic location. Medicines360 is committed to working with healthcare providers, advocacy groups and patients to deliver innovative and meaningful treatments that help women around the world have greater access to the medicines they need. For more information, visit www.medicines360.org.

About Allergan Women’s Healthcare

Allergan is a leader in women’s healthcare that is dedicated to developing and commercializing best-in-class pharmaceuticals to improve the health and wellness of women. Allergan takes a holistic and a best-in-class approach to women’s healthcare as it prioritizes educational partnerships with OB/GYNs and advocacy groups. The mission of Allergan Women’s HealthCare extends beyond its pharmaceutical products to ensure that all women can make informed decisions about their health and have access to high-quality medications. Allergan is committed to investing in programs that support the education and well-being of all women.

About Allergan plc

Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical leader. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.

Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women’s health, urology and anti-infective therapeutic categories.

Allergan is an industry leader in Open Science, a model of research and development, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. With this approach, Allergan has built one of the broadest development pipelines in the pharmaceutical industry.

Allergan’s success is powered by our global colleagues’ commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what is right.

With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.

For more information, visit Allergan’s website at www.Allergan.com.

Forward-Looking Statement

Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan’s current perspective on existing trends and information as of the date of this release. Actual results may differ materially from Allergan’s current expectations depending upon a number of factors affecting Allergan’s business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan’s products; the impact of uncertainty around timing of generic entry related to key products, including RESTASIS®, on our financial results; risks associated with divestitures, acquisitions, mergers and joint ventures; uncertainty associated with financial projections, debt reduction, projected cost reductions, projected synergies, restructurings, increased costs, and adverse tax consequences; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan’s periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan’s Annual Report on Form 10-K for the year ended December 31, 2017 and Allergan’s Quarterly Report on Form 10-Q for the period ended June 30, 2018. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

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SOURCE Medicines360